Trial Outcomes & Findings for Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau (NCT NCT03907657)
NCT ID: NCT03907657
Last Updated: 2024-05-21
Results Overview
Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS) versus Brightness Mode Ultrasound (B-mode) in patients at risk for kidney lesions. A dichotomized Bosniak score was used for comparison. Dichotomized Bosniak score: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers. Kidneys were assessed by CEUS and B-mode by three different readers.
COMPLETED
PHASE2
15 participants
Baseline
2024-05-21
Participant Flow
Subjects were enrolled in one center in North Carolina, between 9/23/2019 - 02/13/2023. All considered subjects were eligible, consented, and completed the study. In total 29 kidneys were studied.
Participant milestones
| Measure |
All Subjects
All Patients with genetic diseases at risk of kidney lesions.
|
|---|---|
|
Overall Study Subjects
STARTED
|
15
|
|
Overall Study Subjects
COMPLETED
|
15
|
|
Overall Study Subjects
NOT COMPLETED
|
0
|
|
CEUS
STARTED
|
15
|
|
CEUS
COMPLETED
|
15
|
|
CEUS
NOT COMPLETED
|
0
|
|
B Mode
STARTED
|
15
|
|
B Mode
COMPLETED
|
15
|
|
B Mode
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau
Baseline characteristics by cohort
| Measure |
Patients With a Genetic Disease at Risk of Kidney Lesions
n=15 Participants
Patients with a genetic disease at risk of kidney lesions will be imaged using contrast-enhanced ultrasound with Perflutren.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Patients with a genetic disease at risk of a kidney lesion were imaged using contrast-enhanced ultrasound with Perflutren and B-mode ultrasound. Twenty- nine kidneys belonging to fifteen patients were assessed.
Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS) versus Brightness Mode Ultrasound (B-mode) in patients at risk for kidney lesions. A dichotomized Bosniak score was used for comparison. Dichotomized Bosniak score: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers. Kidneys were assessed by CEUS and B-mode by three different readers.
Outcome measures
| Measure |
CEUS
n=29 Overall Number of Kidneys
Contrast-enhanced ultrasound (CEUS) technique was used to evaluate 29 kidneys belonging to 15 subjects.
|
B-Mode
n=29 Overall Number of Kidneys
Brightness Mode Ultrasound (B-mode) technique was used to evaluate 29 kidneys belonging to 15 subjects.
|
|---|---|---|
|
Comparison in Radiologist's Lesion Evaluation: CEUS Versus B-mode Ultrasound
|
0.13 Dichotomized score
Interval 0.0 to 1.0
|
0.20 Dichotomized score
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Patients with a genetic disease at risk of kidney lesions will be imaged using contrast-enhanced ultrasound with Perflutren.Twenty- nine kidneys belonging to fifteen patients were assessed.
Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS). Potentially malignant lesions were extracted from clinically performed magnetic resonance imaging (MRI) completed within 4 months of CEUS. Dichotomized Bosniak scores from CEUS were compared with MRI-derived malignancy scores. Dichotomized Bosniak scores: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers.
Outcome measures
| Measure |
CEUS
n=29 Overall Number of Kidneys
Contrast-enhanced ultrasound (CEUS) technique was used to evaluate 29 kidneys belonging to 15 subjects.
|
B-Mode
n=29 Overall Number of Kidneys
Brightness Mode Ultrasound (B-mode) technique was used to evaluate 29 kidneys belonging to 15 subjects.
|
|---|---|---|
|
Comparison in Radiologist's Lesion Evaluation: CEUS Versus Clinically Performed MRI
|
0.13 Dichotomized score
Interval 0.0 to 1.0
|
0.10 Dichotomized score
Interval 0.0 to 1.0
|
Adverse Events
Patients With a Genetic Disease at Risk of Kidney Lesions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melahat Canter
University of North Carolina Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place